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Zofran Birth Defects

baby holding father's handUltimately gaining tremendous popularity as an anti-nausea medication, Zofran (ondansetron) first reached the American market back in 1991. Specifically designed to combat nausea and vomiting resulting from chemotherapy treatment of cancer patients, Zofran has also been widely prescribed to expectant mothers suffering from the most severe form of morning sickness known as hyperemesis gravidarum.

Despite the common practice of giving Zofran to pregnant patients, concern has begun to develop concerning allegations of a link between this use of the medication and the emergence of serious birth defects in babies born to mothers who took it.

Off-label use of Zofran for morning sickness

Roughly 8 out of 10 expectant mothers experience morning sickness to one degree or another, and in some, the vomiting and nausea can become crippling and dangerous to the health of both mother and child. Hyperemesis gravidarum can result in severe dehydration, drastic weight loss, malnutrition and even muscle wasting. Thus, the existence of an effective anti-nausea medication such as Zofran has long been celebrated by pregnant women and their physicians alike.

However, this particular use of Zofran never received approval from the U.S. Food and Drug Administration, and there has not been a great deal of research performed in order to assess its safety. While it’s true that the FDA has not promulgated any clear warnings about Zofran use by pregnant women, the agency has issued alerts to the public and the medical community regarding the possible existence of complications in patients with known heart conditions. For some, this fact underscores the need for additional research on the effects of Zofran on unborn fetuses.

Zofran birth defect studies

Multiple studies conducted in recent years have caused concern regarding Zofran use during pregnancy and its alleged potential to cause birth defects. In 2013, the New England Journal of Medicine presented a study which found no link between this particular application and a rise in birth defects. The study utilized information gleaned from the Danish Medical Birth Registry for the years 2004-2011. However, critics have underscored methodological weaknesses in the research which could have skewed the outcome.

Another study was undertaken using a larger sample of Danish Medical Birth Registry data, and the results differed from the initial survey significantly. The study authors asserted that Zofran use in pregnancy was linked to a doubling of the risk of heart defects in infants and an increase of 30 percent  in the overall risk of birth defects. Whereas 3.5 percent of women who did not take Zofran while pregnant gave birth to infants with defects, 4.7 percent of those who did use the drug had babies with defects.

Cleft palate and atrial septal defects of the heart were some of the most noteworthy defects observed, though other problems allegedly linked to Zofran include:

  • Jaundice
  • Heart murmur
  • Skull deformities
  • Fetal growth restriction
  • Kidney malfunctions

Cleft palate

A severe birth defect marked by improper formation of the mouth and its surrounding structures in utero, cleft palate can cause a lifetime of problems for the children it affects. This particular defect is the result of a failure of tissues in the roof of the mouth to properly join during early pregnancy, often causing the palate to remain open. Children with cleft palate often experience difficulties speaking, eating and may have an increased susceptibility to ear infections. It is not uncommon for these patients to suffer from dental issues and hearing problems as well.

Infants suffering from cleft palate must often undergo surgery in their first months of life. Additional interventions may be necessary as the child grows, including intensive treatments, therapies and further operations. Many with cleft palate experience issues with self esteem as they grow because of their noticeable differences in appearance.

Zofran and atrial septal defects

An especially alarming allegation concerning Zofran use in pregnancy is that it may be responsible for an increase in the risk of atrial septal defect in infants. The condition is marked by a distinct hole in the wall that separates the heart’s upper chambers. Atrial septal defects can be extremely serious, particularly if they go undetected. Heart and lung damage can result, and surgical intervention is often necessary in order to limit the potential for severe complications in the youngest sufferers. Adult patients whose atrial septal defects have not been detected may die prematurely or experience a lifetime of lung afflictions, undue fatigue and swelling of their extremities.

Zofran lawsuits on the rise

Growing alarm about the possible connection between Zofran use by pregnant women and birth defects has prompted a wave of litigation that promises to escalate in the coming months and years. Current plaintiffs in Zofran lawsuits commonly allege that GlaxoSmithKline (GSK), the maker of the anti-nausea medication had long been fully aware of the risks posed to unborn children by the drug, yet persisted in encouraging physicians to prescribe it for off-label, unapproved applications.

To bolster their claims of negligence, misrepresentation and deceptive marketing, many plaintiffs point to GSK’s settlement agreement with the U.S. Department of Justice in which the pharmaceutical giant consented to the payment of $3 billion to resolve claims that it allegedly promoted several drugs illegally (including Zofran) and failed to report critical safety data. Despite this settlement, GSK admits no wrongdoing or liability, and continues to stand behind the safety of Zofran and other medications produced by the company.

Birth defect claims filed against GSK

Those pursuing damages against GSK for birth defects allegedly caused by Zofran will be required to establish that the drug maker produced and marketed medications that were dangerous and promoted them without properly warning the public of known risks. Plaintiffs and their attorneys must prove a direct connection between the defect and the use of Zofran during pregnancy.

Lawsuits may be able to secure compensation for losses such as:

  • Current, future and past medical bils
  • Emotional distress
  • Pain and suffering
  • Reduced earning capacity
  • Ongoing therapy and rehabilitation expenses
  • Lost wages

Zofran attorneys across the country are currently reviewing potential birth defect cases, marshaling essential evidence, soliciting expert opinions and testimony, and filing suit on behalf of families who believe that the drug caused serious, lasting physical and psychological harm to their children.

  1. Centers for Disease Congtrol and Prevention, Facts about Cleft Lip and Palate,

  2. U.S. Department of Justice, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data,

  3. Mayo Clinic, Diseases and Coniditions – Atrial septal defect,

  4. U.S. Food and Drug Administration, Ondansetron (marketed as Zofran) Information,

  5. Motherisk, Ondansetron Use In Early Pregnancy And The Risk Of Congenital Malformations – A Register Based Nationwide Cohort Study,